Kornimate/medical-research-clean huggingface dataset:
dietary factors and risk of gallbladder carcinoma in china

Conditions: Dietary Habits

Summary: the purpose of this study is to see how people's diets, other aspects of their lifestyles affect their chances of getting gallbladder carcinoma in china. this survey will enroll 100 patients who have had gallbladder carcinoma，as well as controls with gallstones. the investigators will compare these two groups of subjects to see what factors may lead to gallbladder carcinoma.

the investigators will conduct a case-control study in 10 hospitals from china. cases will be the patients with newly-diagnosed gallbladder carcinoma. the controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. there will be 100 cases with gallbladder carcinoma, 100 controls. the investigators will interview participants about known and potential risk factors for gallbladder carcinoma and obtain information on diet. the investigators will obtain the blood and urine samples for further analysis of metabolomics studies. the investigators will use logistic regression to determine odds ratios for disease with various exposures.

Eligibility criteria:
inclusion criteria: diagnosed with gallbladder carcinoma by imaging tests (cases) diagnosed with chronic cholecystitis by imaging tests (hospital controls) exclusion criteria: the pathology diagnosis and imaging does not matched patients with other malignant tumors patients with other severe systemic diseases

Keywords: dietary exposure gallbladder carcinoma
prolonged tamoxifen compared with shorter tamoxifen in treating patients who have breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can stimulate the growth of breast cancer cells. hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. it is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer. purpose: this randomized phase iii trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

objectives: * assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen. outline: this is a randomized study. after about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years. patients are followed annually. projected accrual: approximately 20,000 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * curatively treated carcinoma of the breast * currently taking adjuvant tamoxifen * must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen) patient characteristics: age: * any age performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant or nursing * no contraindications to receiving tamoxifen * no other serious medical problems prior concurrent therapy: biologic therapy: * prior biologic therapy allowed chemotherapy: * prior chemotherapy allowed endocrine therapy: * see disease characteristics radiotherapy: * prior radiotherapy allowed surgery: * prior surgery allowed

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer
the effects of a model-based sensory stimulation intervention on preventing delirium among intensive care unit patients: a randomised controlled trial

Conditions: Delirium, Intensive Care Unit, Randomised Controlled Trial

Summary: delirium is highly associated with adverse clinical outcomes of intensive care unit (icu) patients, including increased cognitive impairment, duration of intubation, icu length of stay, mortality, physical dependence, and health care costs. this randomised controlled study will firstly develop a family-supported sensory stimulation package based on the literature review as well as the findings of the cross-sectional survey and the in-depth interview. the intervention effects than will be evaluated using outcomes including delirium incidence, delirium duration, delirium severity, icu patients' consciousness and cognitive function as well as family members' satisfaction and anxiety. this study is expected to provide evidence of the effectiveness of family-supported sensory stimulation on preventing delirium among icu patients.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * the first time admitted to icu * a richmond agitation-sedation scale (rass) score ≥-3 exclusion criteria: * diagnosed with stroke, dementia, delirium or acute psychiatric illness at admission * diagnosed with end-stage of cancer * severe hearing impairment and cannot be corrected by hearing aids * admitted to icu with radiative material.

Keywords: delirium, sensory stimulation, intensive care unit, prevention
study in patients with sclc of veliparib in combination with topotecan

Conditions: Small Cell Lung Cancer SCLC

Summary: phase i/ii study in patients with small cell lung cancer (sclc) of veliparib in combination with topotecan

for this study sensitive or refractory sclc patients (refractory to prior chemotherapy defined as having experienced no response or a relapse within 90 days after the end of chemotherapy) will be eligible. in total, around 130 patients will be enrolled, around 30 evaluable patients in phase i and 100 patients in phase ii. the study will consist of two parts: a preceding phase i part will be performed to identify the recommended dose of veliparib to be administered in the phase ii part in combination with topotecan at the dose regimen of 1.25 mg/m2 (on days 1-5 of a 3 week cycle \[d1-5q21d\]). each patient will be subjected to an initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in cycle shall prove topotecan tolerance of the candidates. only patients who do not reveal any dlts receive further treatment with combination therapy. in a dose-escalating 3+3 design the rd of veliparib for the subsequent phase ii part of the study will be defined during a maximum of 5 cycles combination therapy. the phase ii part will follow upon completion of phase i.

Eligibility criteria:
inclusion criteria: * subject must be ≥ 18 years of age * subject with progressive or recurrent ed-sclc after first line platinum-based therapy, which is either histologically or cytologically confirmed * performance status (ps) 0-2 ecog * adequate bone marrow reserve * total bilirubin \< 2 x upper limit of normal * ast and alt \< 2.5 x upper limit of normal, or \< 5 x upper limit of normal in case of liver metastases * serum creatinine \ 50 ml/min exclusion criteria: * other anti-cancer chemotherapy or radiotherapy * symptomatic motor or sensory neuro-toxicities ctcae \> grade 2 or any other unresolved toxicities from prior systemic anti-cancer therapy or radiotherapy ctcae \> grade 1 * known hypersensitivity to topotecan or veliparib * brain or meningeal metastasis (unless they are asymptomatic and not requiring systemic corticosteroid therapy) * major surgery within 6 weeks prior to first treatment on study (subjects must have completely recovered from any previous surgery prior to first treatment on study). * history of cardiac events within the past 3 months * uncontrolled severe hypertension * abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess * uncontrolled nausea / vomiting / diarrhea * previous malignancy (other than sclc) in the last 3 years, except basal cell cancer of the skin, pre-invasive cancer of the cervix, t1a prostate carcinoma or superficial bladder tumor \[ta, tis and t1\] that was cured in the opinion of the investigator. * history of organ allograft * active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis
adoptive transfer of specific melanoma antigens cd8+ t cells in metastatic melanoma patients: a phase i/ii study

Conditions: Metastatic Melanoma

Summary: this study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of cd8+ t cells, sorted with hla-peptide multimers and specific for melan-a and meloe-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages iiic and iv).


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 and ≤ 75 years * patient expressing the hla-a\*0201 subtype of the human leukocyte antigen (hla -a2) * patient with metastatic melanoma stage iiic or iv (ajcc 2010) except brain metastases * tumor expressing the antigens melan-a and meloe-1 detected by rt-pcr * absence of cerebral metastases * ecog ≤ 1 or karnofsky ≥ 80% * prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- braf, anti-ctla4, ifn, til... ) * disease measurable / evaluable within 28 days before the first administration of study treatment * negative viral serology (hiv 1/2, ag p24 , htlv 1/2 , hepatitis b and c, syphilis) * results of analysis: * hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l * leukocytes ≥ 4000/μl * lymphocytes ≥ 1500/μl * platelets ≥ 80.000/μl * creatinine ≤ 2.5 n * total bilirubin ≤ 3 n * ast and alt ≤ 3 n without liver metastases; ≤ 5 n with liver metastases * negative pregnancy test for women of childbearing age * patient affiliated to a social security system * patient who has signed informed consent exclusion criteria: * brain metastases * ocular primitive melanoma * treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion * treatment with ipilimumab within 8 weeks before the inclusion * known allergy to albumin * contraindication to the use of vasopressors * positive viral serology for hiv 1/2 , ag p24 , htlv 1/2, hepatitis b or c, or syphilis * women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline * presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma) * history of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ecg signs of previous myocardial infarction) * uncontrolled thyroid dysfunction * any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study) * history of chronic autoimmune disease (addison's disease, multiple sclerosis, graves' disease, rheumatoid arthritis, systemic lupus erythematosus, ... ) with the exception of patients with active vitiligo or a history of vitiligo * history of uveitis and retinopathy associated with melanoma * adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")

Keywords: onco-dermatology adoptive transfer immunotherapy
retrospective observational study of cotrimoxazole dosing in intensive care unit

Conditions: Acute Kidney Injury

Summary: trimethoprim/sulfamethoxazole (tmp/smx, cotrimoxazole) is the first-line therapy for pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (aki) and renal replacement therapy (rrt) are regularly observed. both may change half-life and subsequent concentrations. specifically, trimethoprim (tmp) is eliminated renally, whereas sulfamethoxazole (smx) elimination is 80%metabolic/20%renal. despite decades of cotrimoxazole use, data in acute kidney injury (aki) are scarce and no consensus on dosing strategy has been established. besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.

the objective is to compare the plasma concentrations of patients with acute renal failure (arf) or requiring extra renal replacement therapy (rrt) with those of patients without these characteristics to look for differences in concentration.

Eligibility criteria:
inclusion criteria: * patient hospitalized in intensive care units between october 2020 and july 2021 with infection treated with cotrimoxazole exclusion criteria: * none

Keywords: cotrimoxazole acute kidney injury renal replacement therapy pharmacodynamic
clinical and economic burden of bleeding events in patients in the uk with non-valvular atrial fibrillation treated with vitamin k antagonists

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to estimate the impact of bleeding events in patients in the uk with non-valvular atrial fibrillation (nvaf) treated with vitamin k antagonists (vka).


Eligibility criteria:
inclusion criteria:- for the cprd-hes cohort, patients will be included if they meet these criteria: * have cprd data linked to hes * have an af diagnosis (based on read codes from cprd or icd-10 codes from hes) and have been treated with vka during the study period -≥18 years old at index date * cprd acceptability quality criteria are present. for the cprd cohort, patients will be included if they meet the following criteria: * have an atrial fibrillation (af) diagnosis (based on read codes from cprd) and have been treated with vkas during the study period * ≥18 years old at index date * cprd acceptability quality criteria are present. exclusion criteria: for the two cohorts of interest, patients will be excluded if they meet the following criteria: * fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). the date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's up-to-standard (uts) date (when the practice is deemed to be contributing data of adequate quality) * the practice is not uts, or the patient is deemed "unacceptable" according to cprd's quality criteria * there is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period * there are records of novel anticoagulant (noac)
study of the influence of pold manual therapy in fibromyalgia

Conditions: Fibromyalgia

Summary: this clinical research aims to study the effects of the introduction of pold manual therapy within the protocol of fibromyalgia

this research project aims to generate scientific evidence on the clinical results obtained in the treatment of fibromyalgia, which usually presents with pain and long-term disability, by applying a special form of manual physiotherapy called "pold concept". this therapy is based on a passive, oscillatory mobilization, performed at a resonance frequency and applied throughout the time of the therapeutic session, on the vertebrae and the muscles of the back, without interruption. it is carried out on the initiative of the research team in "pain treatment", of the physiotherapy school of the university of lleida, in collaboration with the omphis foundation and the clinical service of the unity of fibromyalgia of gss (hospital universitarios de santa maría, lleida)

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with fibromyalgia 2. patients over 25 years old and up to 65 years old, regardless of whether they are women or men. 3. patients who present pain with a minimum value of 5 on the numerical pain scale from 0 to 10, at the time of beginning the study. 4. presence of these symptoms in a long period (more than 6 months) exclusion criteria: 1. patients with a recent traumatic history. 2. presence of an irradiation component of neurological origin to upper or lower limbs 3. patients with neurological alterations, both central and peripheral. 4. patients who are taking opioid-based analgesic medication. 5. patients with severe spinal malformations. 6. that they are following any other type of treatment, whether manual or physical agents or alternative or complementary therapies. 7. that they have been treated with infiltrations or similar in a period of less than one year before beginning the study. 8. patients with a serious psychiatric history such as schizophrenia or psychopathies. 9. patients who have vestibular problems that do not tolerate oscillation. 10. patients with heart failure 11. existence of judicial process of disability

Keywords: fibromyalgia chronic pain
effect of renal impairment on the pharmacokinetics of nn9535

Conditions: Diabetes; Diabetes Mellitus, Type 2; Renal Impairment

Summary: this trial is conducted in the united states of america (usa). the aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of nn9535.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject) * subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft \& gault formula) for any of the renal function groups * body mass index (bmi) equal to or less than 40kg/m2 exclusion criteria: * known or suspected allergy to trial product(s) or related products * renal transplanted patients * certain cardiac problems (heart failure, unstable angina, mi (myocardial infarction) within the last 3 months) * known current hepatic dysfunction or severe hepatic disease during the last 12 months * female of childbearing potential/breast feeding * history of alcoholism or drug abuse * blood donation during the last 8 weeks prior to the study * past or current history of pancreatitis
dual fsh/hcg trigger in letrozole stimulated intrauterine insemination cycles in women with unexplained infertility

Conditions: Unexplained Infertility

Summary: the objective of this study was to evaluate the outcome of follicle stimulating hormone (fsh) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (uei) and assigned for letrozole (ltz) stimulated intrauterine insemination (iui) cycles .

this prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the gynecology outpatient clinics of, benha university hospital, and private settings, alkalubia, egypt from jun 2013 to aug 2015. the study protocol was approved by the local ethics committee and written informed consents were taken from both partners before starting of the study. all women received the same regimen of ovarian stimulation using letrozole (femara; novartis pharma ag, basle, switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. transvaginal ultrasound scan (tvs) was performed daily from cycle day 9 and a total of 10,000 iu of hcg (epifasi, epico) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. on the day of hcg administration women were randomly categorized into two groups according to a computer generated random numerical table. envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. group a received fsh (urofollitropin; fostimon, ibsa, bazel, swiz; 75 iu amp) 150 iu injected once on day of hcg injection and group b received no fsh on day of hcg injection. intrauterine insemination was performed 36 hours after hcg injection. women in both groups received luteal phase support in the form of vaginal progesterone, (prontogest 400 mg vaginal pessaries, ibsa) twice a day, starting from the day after iui and continued till the eighth week, if the pregnancy test was positive.two weeks later, quantitative ßhcg was estimated to diagnose chemical pregnancy. however, tvs was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. all women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.

Eligibility criteria:
inclusion criteria: * unexplained infertility for more than 2 years * normal ovulation proved by midluteal serum progesterone level \>5 ng/ml, * patent fallopian tubes confirmed by hysterosalpingography or laparoscopy * normal semen analysis according to the modified world health organization (who) criteria * normal hormonal profile (fsh, lh, prolactin and tsh) in the early follicular phase. exclusion criteria: * other causes of infertility ( tubal factors, polycystic ovary syndrome (pcos), endometriosis) * ovarian cysts, * fsh \>10 miu/ml. * previous intrauterine insemination (iui )cycles, * liver or kidney diseases, * hypersensitivity to the used medications.
hiv cohort study at johns hopkins university, university of north carolina at chapel hill and vanderbilt university

Conditions: HIV; AIDS

Summary: human immunodeficiency virus (hiv) infected patients in the hiv registries of johns hopkins university, university of north carolina and vanderbilt university will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population.

all patients identified in the hiv registries will be included without any sampling

Eligibility criteria:
inclusion criteria: * hiv infection. exclusion criteria: * none.
the smartlipo triplex 1440nm wavelength laser and the sidelaze 800 hand piece for the treatment of facial acne scars

Conditions: Acne Scars

Summary: the purpose of this study to evaluate the smartlipo triplex laser system along with the sidelaze800 hand piece in the treatment of acne scars.


Eligibility criteria:
inclusion criteria: * a healthy male or female between 18 and 65 years old * has unwanted facial acne scars and wishes to undergo laser treatments. * is willing to consent to participate in the study. * is willing to comply with all requirements of the study including being photographed, following post treatment care and attending follow up visits. exclusion criteria: * the subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. * the subject is hypersensitive to light exposure or takes photo sensitized medication. * the subject has active or localized systemic infections. * the subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin) {greater than 81 mg per day}). * the subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the planned treatment area 3 months prior to entering this study. * the subject has used accutane within 6 months prior to enrollment. * the subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. * the subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). * the subject has a history of keloids. * the subject has evidence of compromised wound healing. * the subject has a history of squamous cell carcinoma or melanoma. * the subject has a history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. * the subject has an allergy to lidocaine and epinephrine. * the subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.